Demyelinating Diseases of the Central Nervous SystemPEDI-CORENCT07654738
Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases
An observational study of Demyelinating Diseases of the Central Nervous System and Child, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate balance ability, core stability, functional capacity, lower extremity muscle strength, and fatigue levels in children diagnosed with central nervous system demyelinating diseases, in order to contribute to the development of evidence-based and individualized rehabilitation strategies. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Demyelinating Diseases of the Central Nervous System, Child, Core Stability
- What is being tested?
- No ADT
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Aug 2026to 30 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will be conducted with pediatric patients diagnosed with demyelinating diseases (Multiple Sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)) who are referred to our center.
Who may be able to join
- Age between 6 and 18 years
- Diagnosed with a pediatric demyelinating disease
- No relapse within the last 3 months
- No botulinum toxin (Botox) injections within the last 3 months
- No corticosteroid treatment within the last 3 months
- Ability to read and write
Who cannot join
- History of concomitant autoimmune diseases
- Refusal of the patient and/or caregiver to participate in the study
- History of another primary neurological disease
- Cognitive impairment that limits understanding of instructions and participation in assessments
- Visual and/or hearing impairments that interfere with activities of daily living
- Presence of additional rheumatological conditions that may interfere with assessments
- Spasticity grade ≥2 according to the Modified Ashworth Scale in any muscle group
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital, Istanbul, Türkiye
Istanbul, Basaksehir, 34480
Tahire Basak Demir, PhD (c), +90 (212) 213 64 86 ext. 203, tahirebasakdemir@gmail.com
About this study
Official title: Investigation of the Relationship Between Core Stability, Functional Capacity, Balance, Lower Extremity Strength, and Fatigue in Pediatric Demyelinating Diseases
This study aims to evaluate balance ability, core stability, functional capacity, lower extremity muscle strength, and fatigue levels in children diagnosed with central nervous system demyelinating diseases, in order to contribute to the development of evidence-based and individualized rehabilitation strategies.
Read the detailed description
Central nervous system demyelinating diseases in childhood, including multiple sclerosis, neuromyelitis optica spectrum disorder, and acute disseminated encephalomyelitis, are rare but may result in significant physical and cognitive impairments. These conditions arise from immune-mediated damage to the white matter of the brain, optic nerve, and spinal cord, leading to disruptions in neuromotor development.
Motor dysfunction, fatigue, and reduced physical activity are commonly observed in affected children and are associated with decreased functional capacity and quality of life. In addition, impaired postural stability due to disrupted integration of proprioceptive, vestibular, and visual systems contributes to balance deficits, increased fall risk, gait abnormalities, and reduced participation in daily activities.
Core stabilization plays a fundamental role in motor development and functional movement by ensuring efficient postural control and force transfer through the kinetic chain. However, central nervous system pathology may impair the timely and coordinated activation of core musculature.
Despite growing literature in adult populations, pediatric evidence remains limited, which restricts the development of individualized rehabilitation approaches. Therefore, this study will assess balance, core stability, functional capacity, lower extremity muscle strength, and fatigue in children with demyelinating diseases to better inform clinical rehabilitation strategies.
- Conditions
- Demyelinating Diseases of the Central Nervous System, Child, Core Stability, Balance, Fatigue
- Being tested
- No ADT
- Keywords
- Pediatric Demyelinating Diseases, Core Stability, Balance, Fatigue
- Medical subject headings
- Demyelinating Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No ADTOther
No intervention is administered. Participants will undergo a single assessment including balance evaluation, core stability testing, lower extremity muscle strength assessment, functional capacity tests, and fatigue measurement. All assessments are non-invasive and performed in a single session.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Pediatric Demyelinating Disease Group | Not described Receives: Other: No ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Stability
Core stability (endurance and strength) will be evaluated using standardized trunk endurance tests. The Trunk Flexor Endurance Test measures the duration participants can maintain a 60° trunk flexion position. The Biering-Sørensen Test evaluates trunk extensor endurance in a prone horizontal position supported at the pelvis and lower limbs, recording the time until loss of horizontal alignment. The Side Bridge Test assesses lateral trunk endurance while maintaining a side plank position. All results will be recorded in seconds.
Measured: Baseline (single assessment)
Modified Star Excursion Balance Test (mSEBT)
The Modified Star Excursion Balance Test (mSEBT) will be used to assess dynamic postural control. The test consists of three reach directions: anterior, posteromedial, and posterolateral, with the posterior directions positioned at 90° to each other and each forming a 135° angle with the anterior direction. Participants will stand barefoot on the tested limb at the intersection of the three lines and reach as far as possible along each direction with the contralateral limb while maintaining balance and without transferring body weight onto the reaching limb. Before testing, standardized practice trials will be provided to minimize learning effects. Three recorded trials will be performed in each direction for each limb, and the maximum reach distance will be recorded. Reach distances will be normalized to limb length and expressed as a percentage using the formula: (maximum reach distance / limb length) × 100. A composite reach score will also be calculated by averaging the normalized
Measured: Baseline (single assessment)
6-Minute Walk Test (6MWT)
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) following standardized protocols. Participants will walk at their own pace for 6 minutes on a 30-meter indoor walkway marked every 2 meters, with turnaround points marked by cones. The total distance walked in meters will be recorded.
Measured: Baseline (single assessment)
Timed Up and Go Test (TUG)
For TUG, the person gets up from the chair, walks 3 m, turns back and sits down again. The test will be conducted using the same chair for every child, and the time will be recorded in seconds.
Measured: Baseline (Single Assessment)
Secondary outcomes (3)
30-Second Sit-to-Stand Test
Lower extremity muscle strength and functional performance will be assessed using the 30-Second Sit-to-Stand Test. Participants will perform repeated sit-to-stand movements from a standardized chair for 30 seconds. The total number of full stands completed within the time period will be recorded.
Measured: Baseline (single assessment)
Fatigue Severity Scale (FSS)
Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a 9-item questionnaire rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The final score is calculated as the mean of all items, with higher scores indicating greater fatigue severity.
Measured: Baseline (single assessment)
Fatigue Numeric Rating Scale (NRS-Fatigue)
Fatigue intensity will be measured using a 0-10 Numeric Rating Scale, where 0 indicates no fatigue and 10 indicates worst imaginable fatigue. Participants will report fatigue levels during activity, at rest, and over the last 24 hours, as well as perceived fatigue over the past week.
Measured: Past 24 hours and past 1 week (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Demyelinating Diseases of the Central Nervous SystemStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahire Basak Demir, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654738
- Sponsor's protocol ID
- 2025/451
- Acronym
- PEDI-CORE
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual participant data (IPD) will not be shared. All study records will be destroyed 2 years after study completion.
Publications
Toussaint-Duyster LC, Wong YYM, Van der Cammen-van Zijp MH, Van Pelt-Gravesteijn D, Catsman-Berrevoets CE, Hintzen RQ, Neuteboom RF. Fatigue and physical functioning in children with multiple sclerosis and acute disseminated encephalomyelitis. Mult Scler. 2018 Jun;24(7):982-990. doi: 10.1177/1352458517706038. Epub 2017 Apr 26.
PubMed 28445083Tardieu M, Banwell B, Wolinsky JS, Pohl D, Krupp LB. Consensus definitions for pediatric MS and other demyelinating disorders in childhood. Neurology. 2016 Aug 30;87(9 Suppl 2):S8-S11. doi: 10.1212/WNL.0000000000002877.
PubMed 27572866Gulati S, Chakrabarty B, Kumar A, Jain P, Patel H, Saini L. Acquired demyelinating disorders of central nervous system: A pediatric cohort. Ann Indian Acad Neurol. 2015 Sep;18(Suppl 1):S48-55. doi: 10.4103/0972-2327.164829.
PubMed 26538849Hertel. J., Miller. S. J., Denegar. C. R. (2000). Intratester and intertester reliability during the star excursion balance tests. Journal of sport rehabilitation, 9-(2), 104-116.
Gladman D, Nash P, Goto H, Birt JA, Lin CY, Orbai AM, Kvien TK. Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis. RMD Open. 2020 Jan;6(1):e000928. doi: 10.1136/rmdopen-2019-000928.
PubMed 31958274Gowda VK, Shetty D, Madivala BV, Benakappa N, Benakappa A. Clinical and Radiological Profiles, Treatment, and Outcome of Pediatric Acquired Demyelinating Disorders of Central Nervous System. J Pediatr Neurosci. 2019 Apr-Jun;14(2):76-81. doi: 10.4103/jpn.JPN_62_18.
PubMed 31516624Erden A, Acar Arslan E, Dundar B, Topbas M, Cavlak U. Reliability and validity of Turkish version of pediatric balance scale. Acta Neurol Belg. 2021 Jun;121(3):669-675. doi: 10.1007/s13760-020-01302-9. Epub 2020 Feb 19.
PubMed 32077065Al-Hameed, A. A. K. (2022). Spearman's correlation coefficient in statistical analysis. International Journal of Nonlinear Analysis and Applications, 13(1), 3249-3255.
Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil. 2004 Mar;85(3 Suppl 1):S86-92. doi: 10.1053/j.apmr.2003.12.005.
PubMed 15034861Absoud M, Cummins C, Chong WK, De Goede C, Foster K, Gunny R, Hemingway C, Jardine P, Kneen R, Likeman M, Lim MJ, Pike M, Sibtain N, Whitehouse WP, Wassmer E. Paediatric UK demyelinating disease longitudinal study (PUDDLS). BMC Pediatr. 2011 Jul 28;11:68. doi: 10.1186/1471-2431-11-68.
PubMed 21798048
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Core Stability, Functional Capacity, Balance, Lower Extremity Strength, and Fatigue in Pediatric Demyelinating Diseases
- ClinicalTrials.gov ID
- NCT07654738
- Acronym / sponsor ID
- PEDI-CORE / 2025/451
- Conditions
- Demyelinating Diseases of the Central Nervous System, Child, Core Stability, Balance, Fatigue
- Keywords
- Pediatric Demyelinating Diseases, Core Stability, Balance, Fatigue
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate balance ability, core stability, functional capacity, lower extremity muscle strength, and fatigue levels in children diagnosed with central nervous system demyelinating diseases, in order to contribute to the development of evidence-based and individualized rehabilitation strategies.
Detailed description
Central nervous system demyelinating diseases in childhood, including multiple sclerosis, neuromyelitis optica spectrum disorder, and acute disseminated encephalomyelitis, are rare but may result in significant physical and cognitive impairments. These conditions arise from immune-mediated damage to the white matter of the brain, optic nerve, and spinal cord, leading to disruptions in neuromotor development.
Motor dysfunction, fatigue, and reduced physical activity are commonly observed in affected children and are associated with decreased functional capacity and quality of life. In addition, impaired postural stability due to disrupted integration of proprioceptive, vestibular, and visual systems contributes to balance deficits, increased fall risk, gait abnormalities, and reduced participation in daily activities.
Core stabilization plays a fundamental role in motor development and functional movement by ensuring efficient postural control and force transfer through the kinetic chain. However, central nervous system pathology may impair the timely and coordinated activation of core musculature.
Despite growing literature in adult populations, pediatric evidence remains limited, which restricts the development of individualized rehabilitation approaches. Therefore, this study will assess balance, core stability, functional capacity, lower extremity muscle strength, and fatigue in children with demyelinating diseases to better inform clinical rehabilitation strategies.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Pediatric Demyelinating Disease Group | – | Other: No ADT |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will be conducted with pediatric patients diagnosed with demyelinating diseases (Multiple Sclerosis (MS), Acute Disseminated Encephalomyelitis (ADEM), Neuromyelitis Optica Spectrum Disorder (NMOSD), and Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)) who are referred to our center.
Key inclusion criteria (6 listed)
- Age between 6 and 18 years
- Diagnosed with a pediatric demyelinating disease
- No relapse within the last 3 months
- No botulinum toxin (Botox) injections within the last 3 months
- No corticosteroid treatment within the last 3 months
Key exclusion criteria (7 listed)
- History of concomitant autoimmune diseases
- Refusal of the patient and/or caregiver to participate in the study
- History of another primary neurological disease
- Cognitive impairment that limits understanding of instructions and participation in assessments
- Visual and/or hearing impairments that interfere with activities of daily living
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No ADTNo intervention is administered. Participants will undergo a single assessment including balance evaluation, core stability testing, lower extremity muscle strength assessment, functional capacity tests, and fatigue measurement. All assessments are non-invasive and performed in a single session. | Other | Group 1: Pediatric Demyelinating Disease Group |
Primary outcome
Core Stability
Time frame: Baseline (single assessment)
Core stability (endurance and strength) will be evaluated using standardized trunk endurance tests. The Trunk Flexor Endurance Test measures the duration participants can maintain a 60° trunk flexion position. The Biering-Sørensen Test evaluates trunk extensor endurance in a prone horizontal position supported at the pelvis and lower limbs, recording the time until loss of horizontal alignment. The Side Bridge Test assesses lateral trunk endurance while maintaining a side plank position. All results will be recorded in seconds.
Modified Star Excursion Balance Test (mSEBT)
Time frame: Baseline (single assessment)
The Modified Star Excursion Balance Test (mSEBT) will be used to assess dynamic postural control. The test consists of three reach directions: anterior, posteromedial, and posterolateral, with the posterior directions positioned at 90° to each other and each forming a 135° angle with the anterior direction. Participants will stand barefoot on the tested limb at the intersection of the three lines and reach as far as possible along each direction with the contralateral limb while maintaining balance and without transferring body weight onto the reaching limb. Before testing, standardized practice trials will be provided to minimize learning effects. Three recorded trials will be performed in each direction for each limb, and the maximum reach distance will be recorded. Reach distances will be normalized to limb length and expressed as a percentage using the formula: (maximum reach distance / limb length) × 100. A composite reach score will also be calculated by averaging the normalized
6-Minute Walk Test (6MWT)
Time frame: Baseline (single assessment)
Functional capacity will be assessed using the 6-Minute Walk Test (6MWT) following standardized protocols. Participants will walk at their own pace for 6 minutes on a 30-meter indoor walkway marked every 2 meters, with turnaround points marked by cones. The total distance walked in meters will be recorded.
Timed Up and Go Test (TUG)
Time frame: Baseline (Single Assessment)
For TUG, the person gets up from the chair, walks 3 m, turns back and sits down again. The test will be conducted using the same chair for every child, and the time will be recorded in seconds.
3 secondary outcomes
30-Second Sit-to-Stand Test
Time frame: Baseline (single assessment)
Fatigue Severity Scale (FSS)
Time frame: Baseline (single assessment)
Fatigue Numeric Rating Scale (NRS-Fatigue)
Time frame: Past 24 hours and past 1 week (single assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 28445083Toussaint-Duyster LC, Wong YYM, Van der Cammen-van Zijp MH, Van Pelt-Gravesteijn D, Catsman-Berrevoets CE, Hintzen RQ, Neuteboom RF. Fatigue and physical functioning in children with multiple sclerosis and acute disseminated encephalomyelitis. Mult Scler. 2018 Jun;24(7):982-990. doi: 10.1177/1352458517706038. Epub 2017 Apr 26.
- Background: PubMed 27572866Tardieu M, Banwell B, Wolinsky JS, Pohl D, Krupp LB. Consensus definitions for pediatric MS and other demyelinating disorders in childhood. Neurology. 2016 Aug 30;87(9 Suppl 2):S8-S11. doi: 10.1212/WNL.0000000000002877.
- Background: PubMed 26538849Gulati S, Chakrabarty B, Kumar A, Jain P, Patel H, Saini L. Acquired demyelinating disorders of central nervous system: A pediatric cohort. Ann Indian Acad Neurol. 2015 Sep;18(Suppl 1):S48-55. doi: 10.4103/0972-2327.164829.
- BackgroundHertel. J., Miller. S. J., Denegar. C. R. (2000). Intratester and intertester reliability during the star excursion balance tests. Journal of sport rehabilitation, 9-(2), 104-116.
- Background: PubMed 31958274Gladman D, Nash P, Goto H, Birt JA, Lin CY, Orbai AM, Kvien TK. Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis. RMD Open. 2020 Jan;6(1):e000928. doi: 10.1136/rmdopen-2019-000928.
- Background: PubMed 31516624Gowda VK, Shetty D, Madivala BV, Benakappa N, Benakappa A. Clinical and Radiological Profiles, Treatment, and Outcome of Pediatric Acquired Demyelinating Disorders of Central Nervous System. J Pediatr Neurosci. 2019 Apr-Jun;14(2):76-81. doi: 10.4103/jpn.JPN_62_18.
- Background: PubMed 32077065Erden A, Acar Arslan E, Dundar B, Topbas M, Cavlak U. Reliability and validity of Turkish version of pediatric balance scale. Acta Neurol Belg. 2021 Jun;121(3):669-675. doi: 10.1007/s13760-020-01302-9. Epub 2020 Feb 19.
- BackgroundAl-Hameed, A. A. K. (2022). Spearman's correlation coefficient in statistical analysis. International Journal of Nonlinear Analysis and Applications, 13(1), 3249-3255.
- Background: PubMed 15034861Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil. 2004 Mar;85(3 Suppl 1):S86-92. doi: 10.1053/j.apmr.2003.12.005.
- Background: PubMed 21798048Absoud M, Cummins C, Chong WK, De Goede C, Foster K, Gunny R, Hemingway C, Jardine P, Kneen R, Likeman M, Lim MJ, Pike M, Sibtain N, Whitehouse WP, Wassmer E. Paediatric UK demyelinating disease longitudinal study (PUDDLS). BMC Pediatr. 2011 Jul 28;11:68. doi: 10.1186/1471-2431-11-68.
- ArticleLink provided by the sponsor.
- ArticleLink provided by the sponsor.
- ArticleLink provided by the sponsor.
- ArticleLink provided by the sponsor.
- Individual participant dataSharing planned: No. No, individual participant data (IPD) will not be shared. All study records will be destroyed 2 years after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Demyelinating Diseases of the Central Nervous System and Child, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tahire Basak Demir, PhD (c) (+90 (212) 213 64 86 ext. 203, tahirebasakdemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Stability (time frame: Baseline (single assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07654738, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.